Personalized Molecular Profiling in Cancer Treatment at Johns Hopkins

Not Applicable

Active, not recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Other: Treatment recommendation

• Registration Number: NCT02965755
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions.

Detailed Description

The goal of this research study is to determine if we can obtain personalized genetic information from a subject's blood sample that is similar to that obtained from a tumor tissue sample, and if we can use that information to make treatment suggestions. As tumor samples can be difficult to collect, we hope to be able to collect similar genetic information from blood or urine samples that we find in tumor tissue. Ultimately, we hope to identify genes important to cancer cells that could potentially identify standard-of-care or research-based recommendations for therapy.

Study Timeline

• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-11-14
• Study First Posted: 2016-11-17
• Study Start: 2018-01-26
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Male or Female
• 18 years of age or older
• Metastatic breast cancer and treatment with prior chemotherapy
• Any clinical phenotype (Triple negative, Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-positive)
• Patient must have received a metastatic tumor biopsy within 3 years prior to the date of the first planned blood sample for the study and have tissue available from this biopsy
• Able to voluntarily provide informed consent

Exclusion Criteria

• Women who are pregnant or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genetic profiling	Treatment recommendation	All participants will undergo genetic profiling. Archival tissue will be requested to undergo routine review for possible treatment recommendations. Blood samples will be obtained to study research correlates (plasma tumor DNA, ptDNA) and tissue comparison.

Primary Outcome Measures

Name	Time	Method
Ability of genetically profiling of ptDNA as assessed by identifying the proportion of genetic alterations in tumor tissue	1 year	The proportion of genetic alterations in tumor tissue is detected via genetic profiling of ptDNA when those genetic alterations are present in the tumor at an allelic frequency \>10%.
Percentage of patients who cannot have NGS of metastatic site biopsy but have clinically actionable mutations detected via genetic profiling of ptDNA	1 year	Percentage of patients for which genetic profiling of ptDNA would be more feasible when a metastatic biopsy cannot be acquired.

Secondary Outcome Measures

Name	Time	Method
Response as assessed by change in ptDNA level up to 2 weeks post-intervention. To determine whether a 10-fold decrease in allelic frequency of a given mutation in ptDNA after initiating new systemic therapy can predict for response to treatment.	2 weeks	Change in number-of-folds decrease in allelic frequency of a given mutation in ptDNA 1 or 2 weeks after beginning new systemic therapy.
Response as assessed by Change in Circulating tumor cell (CTC) counts	Change from baseline up to 1 year	Measure CTC counts at baseline, after 1-2 weeks of therapy, and at each restaging, up to 1 year.

Trial Locations

Locations (2)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States

Allegheny Health Network Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States